FDA published a Quality Management System Regulation (QMSR) final rule on February 2, 2024 to revise the current good manufacturing practice (CGMP) requirements for medical devices in the Quality System (QS) Regulation (21 CFR Part 820). FDA amends Part 820 to incorporate the QMS requirements of ISO13485 as references. Replacing the Quality System(QS) with the Quality Management System Regulatio..

With the implementation of the revised Medical Device Management Enforcement Decree (98/2021/ND-CP) in 2021, Vietnam (MoH) extended the registration expiration date for Class C and D medical devices by one year to December 31, 2022, and made distribution registration mandatory from 2022. However, during that period, companies experienced a lot of inconvenience and confusion as the Ministry of He..

On January 15, 2023, Peru's INACAL issued Resolution 022-2023-INACAL/DN on technical standards for household appliances, electric motors, etc. This resolution came into effect on January 16, 2024. The resolution includes the following specifications: standard content remark NTP-IEC 60335-2-32:2023 (Safety) Household and similar electrical appliances. Part 2-32: Specific requirements for massage ..

MIC had collected public opinions on a draft Circular amending and supplementing Circular No. 04/2023/TT-BTTTT until January 27, 2024. As the public consultation was finished, the ministry recently held a meeting with stakeholders to share the comments on the draft and the consultation. The main changes from the draft and the meeting are as follows: 1. Update & synchronize 4 new QCVNs issued in ..

The Hong Kong Medical Device Division (MDD) has announced that the “Essential Principles of Medical Device Safety and Performance” (Technical Reference: TR-004) will be available for use in the Medical Device Administrative Control System (MDACS) from 1 January 2024. Hong Kong's existing reference countries were Australia, Canada, the European Union, Japan, and the United States, but as the info..

On January 1, 2024, India's DPIIT announced a Quality Control Order (QCO) mandating ISI mark certification for electrical accessories such as Cable Trucking and Ducting systems, Bayonet Lamp holders, Live Working Gloves, insulating mats, etc. The products covered by the QCO is as follows: [Table 1] [Table 2] The implementation dates of each tables are as follows: - Table 1: 6 months after the pu..

On January 16, 2024, Chile's MTT published Resolution Nº 31, amending the existing Exempt Resolution Nº 7,219 of 2009 on minimum technical specifications for digital terrestrial TV receivers. The modifications introduced by the resolution will become effective from October 14, 2024. New updates to the existing resolution are as follows: 1. Introduction of definition of receiving antenna in Artic..

MDSAP is a certification system created by five regular member countries, the United States, Japan, Canada, Australia, and Brazil, for the purpose of joint review according to international standards for medical device safety and quality control. From December 19, 2023, the Ministry of Food and Drug Safety revised part of the Medical Device Manufacturing and Quality Control Standards to improve ..

On December 29, 2023, MIC of Vietnam posted the circular 20/2023/TT-BTTTT. The circular approves new standard QCVN 117:2023/BTTTT for GSM, W-CDMA, UTRA Land Mobile User Equipment. The new main points of QCVN 117:2023/BTTTT are as follows: 1. VoLTE is mandatory 2. Additional LTE bands: 1) LTE B28: 703MHz – 733MHz / 758MHz – 788MHz 2) LTE B40: 2300MHz – 2400MHz 3) LTE B41: 2500MHz ~ 2690MHz The ci..

China's CNCA adjusted the conformity assessment system for restricted use of hazardous substances in electrical and electronic products from GB/T 26125 to 8 series standards for the determination of the certain substances - GB/T 39560.1, GB/T 39560.2, GB/T 39560.301, GB/T 39560.4, GB/T 39560.5, GB/T 39560.6, GB/T 39560.701, and GB/T 39560.702 (hereinafter referred to as GB/T 39560 series standar..